Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-03 @ 3:00 PM
Study NCT ID:
NCT03214094
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2017-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004381', 'term': 'Duodenal Ulcer'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.', 'otherNumAtRisk': 1059, 'deathsNumAtRisk': 1059, 'otherNumAffected': 4, 'seriousNumAtRisk': 1059, 'deathsNumAffected': 9, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}], 'seriousEvents': [{'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Motor neurone disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Heart failures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Vascular complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Vascular stent stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Angiocardiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Shunt occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Shunt stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}], 'frequencyThreshold': '0.3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had One or More Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1059'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Case Report Forms Uncollected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}]}]}], 'recruitmentDetails': 'Participants took part in the survey at 121 investigative sites in Japan, from 01 September 2016 to 28 February 2019.', 'preAssignmentDetails': 'Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.2', 'spread': '10.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '309', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '750', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1059', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All participants were enrolled in Japan', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History', 'classes': [{'title': 'Gastric Ulcer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '946', 'groupId': 'BG000'}]}]}, {'title': 'Duodenal Ulcer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with or without medical history of Gastric Ulcer or Duodenal Ulcer was reported.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants could be counted in more than 1 category (including duplicates).'}, {'title': 'Purpose of Low-Dose Aspirin Use', 'classes': [{'title': 'Angina Pectoris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '464', 'groupId': 'BG000'}]}]}, {'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '278', 'groupId': 'BG000'}]}]}, {'title': 'Transient Ischaemic Attack (TIA) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Cerebral Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}]}]}, {'title': 'Others', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants could be counted in more than 1 category (including duplicates).'}, {'title': 'Implantation of Coronary Stent', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Implanted', 'measurements': [{'value': '484', 'groupId': 'BG000'}]}, {'title': 'Not Implanted', 'measurements': [{'value': '575', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Healthcare Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Outpatient', 'measurements': [{'value': '695', 'groupId': 'BG000'}]}, {'title': 'Inpatient', 'measurements': [{'value': '364', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized as outpatient and inpatient.', 'unitOfMeasure': 'Participants'}, {'title': 'Predisposition to Hypersensitivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Predisposition to Hypersensitivity', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'Had No Predisposition to Hypersensitivity', 'measurements': [{'value': '918', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Medical Complications', 'measurements': [{'value': '971', 'groupId': 'BG000'}]}, {'title': 'Had No Medical Complications', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '927', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '160.52', 'spread': '9.361', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '949', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61.92', 'spread': '12.591', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.96', 'spread': '3.710', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'Kilogram (kg)/meter (m)^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Helicobacter Pylori Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Helicobacter Pylori Positive', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Helicobacter Pylori Negative', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '936', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with or without medical history of H. pylori was reported.\n\n"Negative" indicates the absence of H. pylori infection, "Positive" indicates presence of the infection.', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '324', 'groupId': 'BG000'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}, {'title': 'Ex-Smoker', 'measurements': [{'value': '394', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drinking Habits', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Current Drinker', 'measurements': [{'value': '226', 'groupId': 'BG000'}]}, {'title': 'Never Drank or Ex Drinker', 'measurements': [{'value': '537', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '296', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Present', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}, {'title': 'Absent', 'measurements': [{'value': '381', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '561', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1059', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Prior Treatment with Acid Suppressants', 'measurements': [{'value': '507', 'groupId': 'BG000'}]}, {'title': 'Had No Prior Treatment with Acid Suppressants', 'measurements': [{'value': '529', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-02', 'size': 516373, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-21T02:34', 'hasProtocol': True}, {'date': '2019-08-07', 'size': 566093, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-21T02:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2017-07-09', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2017-07-09', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-21', 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Had One or More Adverse Drug Reactions', 'timeFrame': 'Up to 12 months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.'}, {'measure': 'Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.'}, {'measure': 'Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.'}, {'measure': 'Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets', 'timeFrame': 'Up to 12 months', 'description': 'Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric or Duodenal Ulcers']}, 'descriptionModule': {'briefSummary': 'The purpose of this survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.', 'detailedDescription': 'The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.\n\nThis survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.\n\nThe survey will enroll approximately 1,000 participants.\n\n\\- Vonoprazan 10 mg\n\nThis multi-center observational survey will be conducted in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The survey population will consist of participants with a diagnosis of gastric or duodenal ulcers and during low-dose aspirin administration in the routine medical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with a history of gastric or duodenal ulcer\n\nExclusion Criteria:\n\n* Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy\n* Participants with active upper gastrointestinal hemorrhage at initiation vonoprazan therapy\n* Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets\n* Participants receiving atazanavir sulfate or rilpivirine hydrochloride'}, 'identificationModule': {'nctId': 'NCT03214094', 'briefTitle': 'Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"', 'orgStudyIdInfo': {'id': 'Vonoprazan-5004'}, 'secondaryIdInfos': [{'id': 'JapicCTI-163435', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vonoprazan 10 mg', 'description': 'The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.', 'interventionNames': ['Drug: Vonoprazan']}], 'interventions': [{'name': 'Vonoprazan', 'type': 'DRUG', 'otherNames': ['Takecab tablets', 'TAK-438'], 'description': 'Vonoprazan tablets', 'armGroupLabels': ['Vonoprazan 10 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Takeda Selected Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}